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The side effects of coal tar in topicals.

The side effects of coal tar in topicalsCoal Tar. Its use in topical medications, the benefits, the consequences.

 

And what does the FDA stipulate?

On the consequences of using coal tar, see also: http://www.health-report.co.uk/psoriasis_cancer_warnings.html

Treating psoriasis with coal tar is a very old and effective remedy. There are both over-the-counter coal tar medications and prescription coal tar medications. The difference is in the potency. Coal tar can be combined with other psoriasis medications (e.g., topical steroids) or with ultraviolet light. Coal tar may make the skin more sensitive to ultraviolet light, and extreme caution is advised when combining its use with UV therapy (or exposure to the sun) in order to avoid getting a severe burn.  The use of Coal tar is banned in Europe.
Tar for instance contains poly-aromatic hydrocarbons (PAH) impurities and naphthalene, which is suspected to cause cancer. Prescription ointments containing increased levels of coal tar mixed with corticosteroids are known to reduce the plaque formation and decrease itching in mild to moderate forms of Psoriasis. Long term use should be avoided however, since they often cause serious side effects. Coal tar basically “burns” away excessive scaly layers of skin and lesions that are caused by the rapid skin cell turnover of the psoriatic skin. Coal tar does add to the inflamed condition and irritation of the skin. Many individuals are sensitive to coal tar. If you use coal tar, you must protect the treated areas from sunlight. If not, you may experience excessive skin burn. Coal tar can lead to skin atrophy, thinning of the skin, stretch marks and discoloring of the skin.

See also: http://ehp.niehs.nih.gov/roc/tenth/profiles/s048coal.pdf

COAL TARS AND COAL TAR PITCHES *

First Listed in the First Annual Report on Carcinogens

CARCINOGENICITY
Coal tars and coal tar pitches are known to be human carcinogens based on sufficient evidence of carcinogenicity in humans (IARC 1985, 1987). There have been a number of case reports of skin cancer in patients who used tar ointments for a variety of skin diseases. A mortality analysis in the United Kingdom from 1946 showed a greatly increased scrotal cancer risk for patent-fuel workers. Furthermore, a large number of case reports describe the development of skin (including the scrotum) cancer in workers exposed to coal tars or coal-tar pitches. Several epidemiological studies have shown an excess of lung cancer among workers exposed to coal tar fumes in coal gasification and coke production. A cohort study of U.S. roofers indicated an increased risk for cancer of the lung and suggested increased risks for cancers of the oral cavity, larynx, esophagus, stomach, skin, and bladder, and for leukemia. Some support for excess risks of lung, laryngeal, and oral cavity cancer is provided by other studies of roofers. Several epidemiological studies have shown excesses of lung and urinary bladder cancer among workers exposed to pitch fumes in aluminium production plants. A slight excess of lung cancer was found among furnace and maintenance workers exposed to coal tar pitch fumes in a calcium carbide production plant. One study showed a small excess of bladder cancer in tar distillers and in patent-fuel workers. An elevated risk of cancer of the renal pelvis was observed in workers exposed to “petroleum or tar or pitch”. One study of millwrights and welders exposed to coal tars and coal tar pitch in a stamping plant showed significant excesses of leukemia and of cancers of the lung and digestive organs (IARC 1987).

When administered topically to experimental animals, coal tars (CAS No.8007-45-2), coal tar extracts, and high-temperature coal tars (CAS No.65996-89-6) induced skin papillomas and carcinomas (IARC 1985).Pharmaceutical coal tars and tar ointments caused skin papillomas, squamous cell carcinomas, and/or carcinomas when applied to the skin of mice of both sexes. When applied to the skin, coal tar induced epidermoid lung carcinomas in rats, and when applied to the ears of rabbits, coal tar caused skin papillomas. When administered intramuscularly, coal tar fume condensate induced injection site sarcomas in mice of both sexes. Analyses of coal tars indicate the presence of a number of known carcinogens and potentially carcinogenic chemicals which are discussed elsewhere in this document, including benz [a ]anthracene,benzo [b ]fluoranthene,benzo [j] fluoranthene,benzo [k ]fluoranthene, benzo [a pyrene, dibenz [a,h ]anthracene, dibenzo [a,i ]pyrene, and indeno [1,2,3-cd ]pyrene (see Polycyclic Aromatic Hydrocarbons, 15 listings). When administered topically or by whole-body exposure, coal tar pitch, a coal tar distillate, induced skin papillomas and carcinomas in mice. When applied topically, coal tar pitch extracts induced skin papillomas and carcinomas in mice; these extracts also had both initiating and promoting activities (in separate studies) in mouse skin. In one study, an extract of a hard residue from a coke oven tar induced lung tumours, but no skin tumours, in mice (IARC 1974). Analyses of coal tar pitches reveal the presence of several carcinogenic polycyclic aromatic hydrocarbons (IARC 1985).

*No separate CAS registry number is assigned to tars.

KNOWN TO BE A HUMAN CARCINOGEN TENTH REPORT ON CARCINOGENS

Coal Tars and Coal Tar Pitches (Continued)

PROPERTIES
Coal tars are by-products of the destructive distillation (carbonization) of coal to produce coke and/or gas. The composition and properties of a coal tar depend primarily on the temperature of the carbonization, and to a lesser extent, on the nature (source) of the coal used as feedstock. They are typically viscous liquids or semisolids that are black or almost black in color and have a characteristic naphthalene-like odor (ATSDR 1996). Coal tars are slightly soluble in water, soluble in benzene and nitrobenzene, and partially soluble in acetone, carbon disulfide, chloroform, diethyl ether, ethanol, methanol, petroleum ether, and sodium hydroxide. In general, coal tars are complex combinations of hydrocarbons, phenols, heterocyclic oxygen, sulphur, and nitrogen compounds. Over 400 compounds have been identified in coal tars and as many as 10,000 may actually be present. The content of polycyclic aromatic hydrocarbons in coal tars increases as the carbonization temperature increases. Low-temperature coal tars (<700 °C) are black, viscous liquids that are denser than water and contain a lower percentage (40%to 50%) of aromatic compounds than high-temperature coal tars (>700 °C) (IARC 1985). Coal tars are highly flammable and corrosive and toxic gases may be released from fires. The vapours can form explosive mixtures with air (HSDB 2001). Coal tar pitch is a shiny, dark brown to black residue produced during the distillation of coal tars. Pitch contains various polycyclic aromatic hydrocarbons, their methyl and polymethyl derivatives, and heteronuclear compounds (IARC 1985).

USE
Coal tar is primarily used for the production of refined chemicals and coal tar products such as creosote, coal tar pitch, and crude naphthalene and anthracene oils from the distillation of crude coal tar. It is also used as a fuel in open-hearth furnaces and blast furnaces in the steel industry. Coal tar is suitable as a fuel because of its availability, its low sulphur content, and its high heating value. Both high-temperature and low-temperature coal tars are used to treat psoriasis and other chronic skin diseases. Coal tar products are also used in numerous pharmaceutical products including creams, ointments, pastes, lotions, bath and body oils, shampoos, soaps, and gels. The coal tar products present in these formulations include coal tars (0.18%to 10%), coal tar solution (2%to 48.5%), coal tar extract (5%), tar distillate (3%to 25%), coal tar fraction (1.25%),and acetyl alcohol coal tar (4%).Coal tar extract is also used in neomycin sulphate-hydrocortisone ointment. USP-grade coal tar is approved for use in denatured alcohol. Coal tar is also used as a binder and filler in surface-coating formulations and as a modifier for epoxy-resin surface coatings (IARC 1985).

Coal tar pitch is primarily used as the binder for aluminium smelting electrodes (IARC 1984). Pitches are also used in roofing materials, surface coatings, black varnishes, and pipe ­ coating enamels. Coal tar pitch is used to impregnate and strengthen the walls of brick refractories. Hard pitch is used as a binder for foundry cores. Coke oven pitch is used to produce pitch coke, which is subsequently used as the carbon component of electrodes, carbon brushes, and carbon and graphite articles. Distillation fractions and residues from high ­temperature coal tars are used in the production of naphthalene, recovery of benzene, production of anthracene paste, briquetting of smokeless solid fuel, impregnation of electrodes and fibers, manufacture of electrodes and graphite, and for road paving and construction (IARC 1985).

KNOWN TO BE A HUMAN CARCINOGEN TENTH REPORT ON CARCINOGENS

Coal Tars and Coal Tar Pitches (Continued)

PRODUCTION
Coal tar was first produced in the United States in 1913, when over 1.0 billion lb were produced as a by-product of coke production (IARC 1985).The majority of coal tar production occurs in the steel industry, and therefore, its production depends on the demand for steel. U.S. production was 168.6 and 188.5 million gallons in 1986 and 1987, respectively (ATSDR 1996). In 1994, the annual U.S. production was 1.8 billion lb (USITC 1995). Six current U.S. suppliers of coal tar and one supplier of coal tar pitch were identified (Chem Sources 2001).

EXPOSURE
The primary routes of potential human exposure to coal tar and coal tar products are inhalation, ingestion, and dermal contact. Occupational exposure of workers to coal tars and pitch may occur during coke production, coal gasification, aluminium production, and at foundries. NIOSH estimated that 145,000 workers were employed in operations that involve coal tar products. OSHA reported that approximately 10,000 coke oven workers were potentially exposed to coal tar in the workplace (IARC 1984). NIOSH reported pitch volatile concentrations (benzene soluble fraction) ranging from 0.4 to 12.0 mg/m 3 as an 8-hr time-weighted average (TWA) at three aluminium production facilities. NIOSH estimated that all workers at these facilities were potentially exposed to pitch volatiles at a concentration of 3.4 mg/m 3 as an 8-hr TWA (NIOSH 1974).Workers in the coal gasification industry and iron and steel foundry industry are also potentially exposed to pitch volatiles including a variety of polycyclic aromatic hydrocarbons (IARC 1984).OSHA estimated that 121,000 workers were potentially exposed to tars, and approximately 2,500 workers at 50 facility locations in the U.S. were potentially exposed to coal tar pitch volatiles (CTPVs) while coating metallic pipes with hot coal tar enamels (Larson 1978).

Exposure of the general population to coal tar may occur through its use in treating skin disorders. Nearly 2%of the United States population is affected by psoriasis, one of the conditions for which coal tar ointments (containing 1%to 10%coal tar) is prescribed (IARC 1985).

The general population may also be exposed to tars that are present as environmental contaminants. Potential occupational exposure to coal tar pitch (usually measured as CTPVs) can occur for workers producing or using pavement tar, roofing tar, coal tar pitch, coal tar paints, coal tar coatings, coal tar enamels, and refractory bricks. NIOSH estimated that approximately 500,000 workers were potentially exposed to asphalt fumes while at work (NIOSH 1979a).The ambient air concentrations of polycyclic aromatic hydrocarbons near roof tarring operations ranged from 0 to 200 µg/m 3, and 0 to 3700 µg/m 3 near pavement tarring operations. Another study found that pitch workers at a U.S. roofing site inhaled up to 53 mg of benzo [a ]pyrene in 7 hours (IARC 1985). NIOSH reported that a felt machine operator was potentially exposed to CTPVs (cyclohexane-soluble fraction) at a concentration of 0.11 mg/m 3. Painters using coal tar paints at a metal products plant were potentially exposed to CTPVs at a TWA concentration of 0.48 mg/m 3 (NIOSH 1980). The concentration of CTPVs (benzene-soluble fraction) at a plant manufacturing a plastic pipe covering (a mixture of coal tar, bitumen, and powdered polyvinyl chloride) ranged from 0.18 to 4.41 mg/m 3 (NIOSH 1976). ndustrial hygiene surveys conducted at eight U.S. plants that coated pipes with coal tar enamel indicated that the mean potential exposure to CTPVs in the coating operations was 1.9 mg/m 3. Coating operators and kettle tenders were potentially exposed to mean concentrations of 6.5 mg/m 3 and 2.3 mg/m 3, respectively (Larson 1978). CTPVs (benzene-soluble fraction) were detected at 0.03 to 3.01 mg/m 3 in several breathing zone and area samples during the carbon-carbon impregnation and densification processes at a United States fiber plant using coal tar pitch (NIOSH 1979b).

KNOWN TO BE A HUMAN CARCINOGEN TENTH REPORT ON CARCINOGENS

Coal Tars and Coal Tar Pitches (Continued)

The potential for skin exposure may be considerable for coal tar and pitch workers because they often wear little clothing due to the heat, thereby exposing large portions of the body to CTPVs. In the skin oil of nine roofing workers (potentially exposed to coal tar pitch and bitumen), 0.048 to 36 ng polycyclic aromatic hydrocarbons were detected for a 36-cm 2 area of the forehead (Wolff et al.1982).

REGULATIONS
EPA regulates coal tars under the Clean Air Act (CAA), setting national emission standards for point and stationary source categories. EPA also regulates tars under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Under the Resource Conservation and Recovery Act (RCRA), wastes containing tars are subject to reporting and record-keeping requirements under the hazardous waste disposal rule. FDA requires warning labels on cosmetics containing coal tar products and has determined that coal tar shampoos are generally recognized as safe. The FDA Advisory Panel on over-the-counter drug products determined that coal tar is not safe for use as a topical antifungal agent. NIOSH has a recommended exposure limit (REL) of 0.1 mg/m 3 for coal tar and coal tar pitch. NIOSH recommends a 15-minute ceiling of 5 mg/m 3 for asphalt fumes. OSHA has established a permissible exposure limit (PEL) of 0.2 mg/m 3 as an 8-hr TWA for CTPVs (benzene-soluble fraction) and 2,000 mg/m 3 for naphtha (petroleum distillates). OSHA also regulates tars as chemical hazards in laboratories under the Hazard Communication Standard. Regulations are summarized in Volume II, Table 48.

REFERENCES
ATSDR. Agency for Toxic Substances and Disease Registry. Toxicological Profile for Wood Creosote, Coal Tar Creosote, Coal Tar, Coal Tar Pitch, and Coal Tar Pitch Volatiles. Update. (Final Report).Atlanta, GA: ATSDR, Public Health Service, U.S.Department of Health and Human Services.1996.254 pp. Chem Sources. Chemical Sources International, Inc. http://www.chemsources.com, 2001.

HSDB. Hazardous Substances Data Bank. Online database produced by the National Library of Medicine. Coal Tar. Profile last updated May 15, 2001.Last review date September 29, 1994. IARC. International Agency for Research on Cancer. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Some Anti-thyroid and Related Substances, Nitrofurans and Industrial Chemicals.Vol.7.326 pp. Lyon, France: IARC, 1974.

IARC. International Agency for Research on Cancer. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Polynuclear Aromatic Compounds, Part 3. Industrial Exposures in Aluminium Production, Coal Gasification, Coke Production, and Iron and Steel Founding.Vol.34.219 pp. Lyon, France: IARC, 1984.

IARC. International Agency for Research on Cancer. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Polynuclear Aromatic 4.Bitumens, Coal Tars and Derived Products, Shale Oils and Soots.Vol.35.271 pp. Lyon, France: IARC, 1985.

KNOWN TO BE A HUMAN CARCINOGEN TENTH REPORT ON CARCINOGENS

Coal Tars and Coal Tar Pitches (Continued)

IARC. International Agency for Research on Cancer. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Overall Evaluations of Carcinogenicity. Supplement 7.440 pp. Lyon, France: IARC, 1987.

Larson, B.A. Occupational Exposure to Coal Tar Pitch Volatiles at Pipeline Protective

Operations.Am.Ind.Hyg.Assoc.J.Vol.39, 1978, pp. 250-255.

NIOSH. National Institute for Occupational Safety and Health. Environmental Surveys of Aluminium Reduction Plants. DHEW (NIOSH) Publication No.74-101.Cincinnati, OH: Department of Health, Education, and Welfare, 1974.

NIOSH. National Institute for Occupational Safety and Health. Health Hazard Evaluation Determination, Protecto Wrap Company, Denver, Colorado. NIOSH Publication No.75-13-265.

Cincinnati, OH: Department of Health, Education, and Welfare, 1976.

NIOSH. National Institute for Occupational Safety and Health. A Recommended Standard for Occupational Exposure to Asphalt Fumes.7 p. Cincinnati, OH: Department of Health, Education, and Welfare, 1979a.

NIOSH. National Institute for Occupational Safety and Health. Hazard Evaluation and

Technical Assistance, Fiber Materials, Inc., Biddeford, Maine. NIOSH Publication No.TA-79-6. Cincinnati, OH: Department of Health, Education, and Welfare, 1979b.

NIOSH. National Institute for Occupational Safety and Health. Health Hazard Evaluation Determination, Continental Columbus Corporation, Columbus, Wisconsin. NIOSH Publication No.78-102-677.Cincinnati, OH: Department of Health and Human Services, 1980.

USITC. U.S. International Trade Commission. Synthetic Organic Chemicals, United States Production and Sales, 1994.USITC Publication No.2933. Washington, DC: U.S. Government Printing Office, 1995.

Wolff, M.S., B.Taffe, R.Boesch, and I.Selikoff. Detection of Polycyclic AroContact Us! matic Hydrocarbons in Skin Oil Obtained from Roofing Workers. Chemosphere Vol.11, 1982, pp. 595-599.

KNOWN TO BE A HUMAN CARCINOGEN TENTH REPORT ON CARCINOGENS
See also: http://www.health-report.co.uk/psoriasis_cancer_warnings.html

And what does the FDA stipulate?

FOOD AND DRUG ADMINISTRATION – Active Ingredients Psoriasis Products

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 358–MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart H–Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis Sec. 358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:

(a) Active ingredients for the control of dandruff.

(1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure.

(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.

(4) Salicylic acid, 1.8 to 3 percent.

(5) Selenium sulfide, 1 percent.

(6) Selenium sulfide, micronized, 0.6 percent.

(7) Sulfur, 2 to 5 percent.

(b) Active ingredients for the control of seborrheic dermatitis.

(1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure.

(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.

(4) Salicylic acid, 1.8 to 3 percent.

(5) Selenium sulfide, 1 percent.

(c) Active ingredients for the control of psoriasis. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Salicylic acid, 1.8 to 3 percent.

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